ISo-17021-2011-Checklist

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Checklist ISO/IEC 17021:2011 Conformity assessment — Requirements for bodies providing audit and certification of management systems Organisation and City Area / field of QMS operation Organisation’s Representative This report Document covers the Review only following: ISO/IEC 17021 Requirement

SANAS

Accr. No/s.

Date

EMS

HACCP

Other?

Document Review and Site Visit

Assessmen t of company files

Assessor Implementation on Site Visit only

CB’s References

COMMENT BY ASSESSOR

5 General requirements 5.1 Legal and contractual matters 5.1.1 Legal responsibility Legal entity or a defined part of a legal entity can be held legally responsible. (Pty) Ltd, CC or other? Verify CIPRO registration. Governmental CB is a legal entity based on its governmental status. Identify department. 5.1.2 Certification agreement Legally enforceable agreement (contract) for provision of certification activities to customer? Are multiple offices of a CB or multiple sites of a certified customer covered by the agreement? Are all the sites covered by the scope of the certification? 5.1.3 Responsibility for certification decisions Does CB retain authority and responsibility for its decisions relating to certification? E.g. granting, maintaining, renewing, extending, reducing, suspending and withdrawing.

5.2

Management of impartiality

5.2.1

Is CB top management commitment to impartiality? Is there a publicly accessible statement? Does it cover: • importance of impartiality • conflict of interest and • objectivity of its management system certification activities?

5.2.2

Are conflict of interests identified, analysed and documented and managed through the system? Are relationships posing a threat to impartiality documented? How does the CB demonstrate that it eliminates or minimizes such threats? Information made available to the Impartiality Committee (see 6.2)? NOTE: A relationship that threatens the impartiality 2012-01-19

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of the certification body can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing and payment of a sales commission or other inducement for the referral of new clients, etc. 5.2.3

Not offering certification when relationships that threaten impartiality cannot be eliminated or minimised. NOTE: See Note to 5.2.2

5.2.4

Does the CB certify another CB for its management system certification activities? NOTE: See Note to 5.2.2 5.2.5

Does the CB and any part of the same legal entity offer or provide management system consultancy? This applies also to that part of government identified as the CB. NOTE: See Note to 5.2.2 5.2.6

Does the CB provide internal audits to its certified customers? Does the CB certify a management system on which it provided internal audits within two years following the end of the internal audits? This applies also to that part of government identified as the CB NOTE: See Note to 5.2.2 5.2.7

Does the CB certify a customer when the CB’s relationship with a management system consultancy or internal audits, poses an unacceptable threat to the impartiality of the CB? See NOTES

5.2.8

Does the CB outsource audits to a management system consultancy organisation? (Unacceptable threat to impartiality, see 7.5). This clause does not apply to individuals contracted as auditors covered in 7.3

5.2.9

Are the CB’s activities marketed or linked with management system consultancy? CB takes action to correct inappropriate claims by any consultancy organisation? Are there any implications by CB that certification would be simpler, easier, faster or less expensive if a specified consultancy organisation is used?

5.2.10 Does CB ensure no conflict of interest of personnel? 2-Years rule applied, how effective is the process? 5.2.11 Is action taken to respond to any threats to CB’s impartiality arising from the actions of other persons, bodies or organisations? 2012-01-19

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5.2.12 Does all CB personnel, internal, external or committees, act impartially and does the CB allow commercial, financial or other pressures to compromise impartiality? 5.2.13 Does the CB require all personnel to reveal any conflict of interest situations? Information used as input to identifying threats to impartiality?

5.3

Liability and financing

5.3.1

Is the CB able to demonstrate that it has evaluated risks arising from its certification activities and that it has adequate arrangements (e.g. insurance or reserves) to cover liabilities arising from its operations in each of its field of activities and the geographic areas in which it operates?

5.3.2

Does the CB evaluate its finances and sources of income and demonstrate to the committee specified in 6.2 that initially and on an on-going basis, commercial, financial or other pressures do not compromise its impartiality?

6 Structural requirements 6.1 Organisational structure and top management 6.1.1

Organisational structure documented, including duties, responsibilities and authorities for personnel and committees; and relationships to other parts within the same legal entity?

6.1.2

Does the CB identify the top management (board, group of persons, or person) having overall authority and responsibility for each of the following: development of policies relating to the operation of the body? supervision of the implementation of the policies and procedures? Supervision of the finances of the body? development of management system certification services and schemes? performance of audits and certification, and responsiveness to complaints? decisions on certification?

a) b) c) d) e) f)

g) delegation of authority to committees or individuals, as required, to undertake defined activities on its behalf? h) contractual arrangements? i) providing adequate resources for certification activities?

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6.1.3

Formal rules for the appointment, terms of reference and operation of any committees involved in the certification activities?

6.2

Committee for safeguarding impartiality

6.2.1

Does the structure of the CB safeguard the impartiality of the activities of the CB and does it provide for a committee to: assist in developing the policies relating to impartiality of its certification activities? counteract any tendency on the part of a CB to allow commercial or other considerations to present the consistent objective provision of certification activities? advise on matters affecting confidence, including openness and public perception? Conduct an annually review of the impartiality of the audit, certification and decision- making processes of the CB?

a) b)

c) d)

COMMENT BY ASSESSOR

6.2.2

Is the composition, terms of reference, duties, authorities, competence of members and responsibilities of this committee formally documented and authorized by the top management of the CB to ensure: a) representation of a balance of interests? b) access to all the information (see also 5.2.2 and 5.3.2)? c) the right to take independent action, where the top management of the CB does not respect the advice of this committee (e.g. informing authorities, ABs, stakeholders)? Is confidentiality maintained when taking independent actions? See 8.5

6.2.3

Are key interests identified and invited to this committee?

7 Resource requirements 7.1 Competence of management and personnel 7.1.1

Does a Certification Body have a process to ensure that personnel have appropriate knowledge relevant to the types of management systems and geographical areas in which it operates? Is competence required for each technical area and for each function in the certification activity determined for each technical area? Is the means for the demonstration of competence determined?

7.1.2

Are competence requirements determined for all CB personnel and is this as per documented process? Is the documented process as per Annexure A or as per certification scheme?

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7.1.3 Evaluation processes Does the CB have documented processes for the initial competence evaluation, and on-going monitoring of competence and performance of all personnel involved in the management and performance of audits and certification? Are these methods effective? 7.1.4

Other considerations

7.1.4.1 Does the CB address the functions undertaken by management and administrative personnel while determining the competence requirements? 7.1.4.2 Does the CB have access to the necessary technical expertise for technical areas, types of management system and geographic areas in which it operates?

7.2

Personnel involved in the certification activities

7.2.1

Does the CB as part of its own organization have personnel with sufficient competence for managing the type and range of audit programmes and other certification work performed?

7.2.2

Does the CB employ or have access to a sufficient number of auditors, including audit team leaders and technical experts to cover all activities and volume of work?

7.2.3

Does the CB make clear to each person concerned their duties, responsibilities and authorities?

7.2.4

Does the CB have defined processes for: • selecting, • training, • formally authorizing auditors and • selecting technical experts? Does the initial competence evaluation of an auditor include the ability to apply required knowledge and skill during audits, as determined by a competent evaluator observing (witnessing) the auditor conducting an audit?

7.2.5

Does the CB have a process to achieve and demonstrate effective auditing, including the use of auditors and audit team leaders possessing generic auditing skills and knowledge, as well as skills and knowledge appropriate for auditing in specific technical areas? Does the CB define the knowledge and skills for specific certification functions as per Annexure A of ISO/IEC 17021:2011?

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7.2.6

Are auditors and technical experts knowledgeable of the CB’s audit processes, certification scheme and its requirements and other relevant requirements? Does the CB give auditors and technical experts access to an up-to-date set of documented procedures giving audit instructions and all relevant information on the certification activities?

7.2.7

Are auditors and technical experts used in these activities where they have demonstrated competence? Note see 9.1.3

7.2.8

Are training needs identified for functions performed? Where there is need, is training offered or provided?

7.2.9

Are person(s) taking the certification decisions knowledgeable on the: • applicable standard; • certification requirements; • and have demonstrated competence to evaluate the audit processes; and • related recommendations of the audit team?

COMMENT BY ASSESSOR

7.2.10 Does documented procedures and criteria for monitoring and measurement of performance of all personnel exist? Competence reviewed to identify training needs? 7.2.11 Do procedures include a combination of onsite observation, review of audit reports and feedback from customers or from the market? 7.2.12 Does the CB periodically observe the performance of each auditor on-site? Is the frequency of on-site observations based on need determined from all monitoring information available?

7.3

Use of individual external auditors and external technical experts

Does a CB have a written agreement with external auditors and external technical experts in place by which they commit themselves to comply with applicable policies and procedures as defined? Does the agreement address all relevant aspects?

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ISO/IEC 17021 Requirement 7.4

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COMMENT BY ASSESSOR

Personnel records

Does the CB maintain up-to-date personnel records, including: • relevant qualifications; • training; • experience; • affiliations; • professional status; • competence; and • any relevant consultancy services? Does this include management and administrative personnel in addition to those performing certification activities?

7.5

Outsourcing

7.5.1

Does the CB have a process in which it describes the conditions under which outsourcing may take place? Legally enforceable agreement with each body that provides outsourced services? See Notes.

7.5.2

Is the CB outsourcing certification decisions?

7.5.3 Does the CB: a) take responsibility for all activities outsourced? b) ensure that the body that provides outsources activities • conforms to the CB’s requirements; • conforms to the applicable provisions of this International Standard, including competence, impartiality and confidentiality? c) ensure that the outsourced services are not involved in any way that impartiality could be compromised? 7.5.4

Documented procedures for the qualification and monitoring of all outsourced services used for certification activities? Records of the competence of auditors and technical experts maintained?

8 Information requirements 8.1 Publicly accessible information 8.1.1

Does the CB maintain and make publicly accessible, or provide upon request, information describing its audit processes, certification processes and about the certification activities, types of management systems and geographical areas in which it operates?

8.1.2

Is the Information provided by the CB to any client or to the marketplace, including advertising, accurate and not misleading?

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ISO/IEC 17021 Requirement 8.1.3

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COMMENT BY ASSESSOR

Does the CB make publicly accessible information about certifications granted, suspended or withdrawn?

8.1.4

Does the CB on request from any party, provide means to confirm the validity of a given certification? See Notes

8.2

Certification documents

8.2.1

Does the CB provide certification documents to the certified client by any means it chooses?

8.2.2

Is the effective date on a certification document, the date before the certification decision?

8.2.3

Does the certification document(s) identify the following: the name and geographic location of each client and any sites within the scope of a multi-site certification? the dates of granting, extending or renewing certification? the expiry date or re-certification due date consistent with the re-certification cycle? a unique identification code? the standard and/or other normative document, including issue number and/or revision, used for audit of the certified customer?

a) b) c) d) e)

f)

the scope of certification with respect to product (including service), process, etc, as applicable at each site? g) the name, address and certification mark of the CB; other marks (e.g. accreditation symbol)? h) any other information required by the standard and/or other normative document used for certification? i) in the event of issuing any revised certification documents, a means to distinguish the revised documents from any prior obsolete documents.

8.3

Directory of certified customers

Does the CB maintain and make publicly accessible or provide upon request, by any means it chooses, a directory of valid certifications? See 8.3 for directory detail.

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8.4

Reference to certification and use of marks

8.4.1

Does the CB have a policy governing any mark that it authorizes certified customers to use? See 8.4.1 and ISO/IEC 17030 for detail. Is the mark used on a product or product packaging seen by the consumer?

8.4.2

Does the CB permit its marks to be applied to laboratory test, calibration or inspection reports?

8.4.3

Does the CB require that the client organisation: conforms to the requirements of the CB when making reference to its certification status in communication media? does not make or permit any misleading statement regarding its certification? does not use or permit the use of a certification document or any part thereof in a misleading manner? upon suspension or withdrawal of its certification, discontinues its use of all advertising matter that contains a reference to certification, as directed by the CB (see 9.6.3 and 9.6.6)? amends all advertising matter when the scope of certification has been reduced? does not allow reference to its management system certification to be used to imply that the CB certifies a product (including service) or process? does not imply that the certification applies to activities that are outside the scope of certification? and does not use its certification in such a manner that would bring the CB and/or certification system into disrepute and lose public trust?

a)

b) c)

d)

e) f)

g)

h)

8.4.4

Does the CB exercise proper control of ownership and take action to deal with incorrect references to certification status or misleading use of certification marks or audit reports? See Note

8.5

Confidentiality

COMMENT BY ASSESSOR

8.5.1/8.5.5 Does the CB through legally enforceable agreements have a policy and arrangements to safeguard the confidentiality of the information at all levels of its structure, including committees and external bodies or individuals acting on its behalf? 2012-01-19

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Client informed by the CB of the confidential information it intends to place in the public domain?

8.5.3

Except as required in this International Standard, is information about a particular client or individual disclosed to a third party without the written consent of the client or individual concerned? Where the CB is required by law to release confidential information to a third party, is the customer or individual concerned, unless regulated by law, notified in advance of the information provided?

8.5.4

Is information about the client treated as confidential, consistent with the CB’s policy?

8.5.5

Do all personnel acting on the CB’s behalf, keep confidential all information obtained or created during the performance of the CB’s activities?

8.5.6

Does the CB have available and use equipment and facilities that ensure the secure handling of confidential information (e.g. documents, records)?

8.5.7

When confidential information is made available to other bodies (e.g. AB, agreement group of a peer assessment scheme) does the CB inform its client of this action?

8.6

Information exchange between a CB and its customers.

CB’s References

Information on the certification activity and requirements Does the CB provide and update clients on the following: a) a detailed description of the initial and continuing certification activity, including the application, initial audits, surveillance audits, and the process for granting, maintaining, reducing, extending, suspending, withdrawing certification and re-certification? b) the normative requirements for certification? c) information about the fees for application, initial certification and continuing certification? d) the CB’s requirements for the prospective customer: 1) to comply with certification requirements? 2) to make all necessary arrangements for the conduct of the audits, including provision for examining documentation and the access to all processes and areas, records and personnel for the purposes of initial certification, surveillance, re-certification and resolution of complaints, and? 3) to make provisions, where applicable, to 2012-01-19 ©SANAS

COMMENT BY ASSESSOR

8.6.1

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accommodate the presence of observers (e.g. accreditation auditors or trainee auditors)? e) documents describing the rights and duties of certified clients, including requirements, when making reference to its certification in communication of any kind in line with the requirements in 8.4? f) information on procedures for handling complaints and appeals? 8.6.2

Notice of changes by a CB Does the CB give its certified clients due notice of any changes to its requirements for certification? Does the CB verify that each certified client complies with the new requirements? See Note.

8.6.3

Notice of changes by a client. Legally enforceable arrangements to ensure that the certified customer informs the CB of matters that may affect the management system’s ability to continue to fulfil the requirements of the standard used for certification? See examples a) to e)

9 Process requirements 9.1 General requirements 9.1.1 Audit programme 9.1.1.1 Is the audit programme for the full certification cycle developed and does it clearly identify the audit activity(ies) required for certification to the selected standard(s) or other normative documents? 9.1.1.2 Does the audit programme include a twostage initial audit, surveillance audits in the 1st and 2nd years, and a re-certification audit in the 3rd year prior to expiration of certification? (The 3-year certification cycle begins with the certification or re-certification decision.) Does the determination of the audit programme and any subsequent adjustments consider the size of the client organisation, the scope and complexity of its management system, products and processes as well as demonstrated level of management system effectiveness and the results of any previous audits? 9.1.1.3 Where a CB is taking account of certification or other audits already granted to the customer, does it collect sufficient, verifiable information to justify and record any adjustments to the audit programme?

9.1.2 Audit plan 9.1.2.1 General Is an audit plan established for each audit to provide the basis for agreement regarding 2012-01-19

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the conduct and scheduling of the audit activities? Is the audit plan based on documented requirements of the certification body? 9.1.2.2 Determining audit objectives, scope and criteria 9.1.2.2.1 Does the CB determine the audit objectives? Is the audit scope and criteria including changes established by the CB after discussions with the client? 9.1.2.2.2 Are audit objectives describe what is to be accomplished by the audit and does it include the following? a) determination of the conformity of the client’s management system, or parts of it, with the audit criteria b) evaluation of the ability of the management system to ensure the client organisation meets applicable statutory, regulatory and contractual requirements SEE NOTE c) evaluation of the effectiveness of the management system to ensure the client organisation is continually meeting its specified objectives d) as applicable, identification of areas for potential improvement of the management system 9.1.2.2.3Does the audit scope describes the extent and boundaries of the audit. Where the initial or re-certification process consists of more than one audit, are total audits consistent with the scope in the certification document? 9.1.2.2.4 Is the audit criteria used as a reference against which conformity is determined and does it include • the requirements of a defined normative document on management systems • the defined processes and documentation of the management system developed by the client 9.1.2.3 Preparing the audit plan Is the audit plan appropriate to the objectives and the scope of the audit and does it at least include or refer to the following: (a) the audit objectives (b) the audit criteria (c) the audit scope, including identification of the organisational and functional units or processes to be audited (d) the dates and sites where the on-site 2012-01-19

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audit activities are to be conducted, including visits to temporary sites, as appropriate (e) the expected time and duration of onsite audit activities (f) the roles and responsibilities of the audit team members and accompanying persons SEE NOTE 1 and 2 9.1.3 Audit team selection and assignments 9.1.3.1 Process in place for selecting and appointing the audit team taking into account the competence needed to achieve the objectives of the audit? Where there is only one auditor, is the auditor competent to perform? 9.1.3.2 In deciding the size and composition of the audit team, was the following considered: (a) audit objectives, scope, criteria and estimated time of the audit (b) whether the audit is a combined, integrated or joint audit (c) the overall competence of the audit team needed to achieve the objectives of the audit (d) certification requirements (including any applicable statutory, regulatory or contractual requirements? (e) Language and culture (f) Whether the members of the audit team have previously audited the client’s management system 9.1.3.3 Where the necessary knowledge and skill of the audit team leader and auditors was supplemented by technical experts, translators and interpreters, were they selected such that they do not unduly influence the audit? 9.1.3.4 Where auditors-in-training are included in the audit team as participants, was an evaluator appointed? Was the evaluator competent to take over the duties and have final responsibility for the activities and findings of the auditor-intraining? 9.1.3.5 Does the audit team leader, in consultation with the audit team assign to each team member responsibility for specific processes, functions, sites, areas or activities and are such assignments taking into account the need for competence? Were changes to assignments made to ensure achievement of the audit objectives?

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9.1.4 Determining audit time 9.1.4.1 Does the CB have documented procedures for determining audit time needed to plan and accomplish a complete and effective audit. Does the procedure include or make reference to the relevant Annexes in the IAF GD2 and GD6 documents? Is the audit time determined by the CB, and the justification for the determination, recorded? In determining the audit time, does the CB consider, among other things, the following aspects: a) the requirements of the management system standard? b) size and complexity? c) technological and regulatory context? d) any outsourcing? e) the results of any prior audits? f) number of sites and multi-site considerations? g) the risks associated with the product, processes or activities of the organisation? h) when audits are combined, joint or integrated? i) specific criteria for specific certification scheme, where established 9.1.4.2 Does the CB include time spent by any team member that is not assigned as an auditor? . 9.1.5 Multi-site sampling Where multi-site sampling is utilized, did the CB develop an adequate sampling programme to ensure proper audit of the management system? Is the rationale for the sampling plan documented? (IAF guidance applies) 9.1.6

a)

b)

c)

d)

Communication of audit team tasks Are the tasks given to the audit team defined and made known to the client? Does the audit team: examine and verify the structure, policies, processes, procedures, records and related documents of the customer organisation relevant to the management system? determine that these meet all the requirements relevant to the intended scope of certification? determine that the processes and procedures are established, implemented and maintained effectively, to provide a basis for confidence in the client management system, and? communicate to the customer, for its action, any inconsistencies between the customer’s policy, objectives and targets and the results?

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9.1.7

Communication concerning audit team members Does the CB provide the name and, when requested, make available background information of each member of the audit team, with sufficient time for the client organisation to object to the appointment of any particular auditor or technical expert and for the CB to reconstitute the team in response to any valid objection?

9.1.8

Communication of audit plan Is the audit plan communicated and the dates of the audit agreed upon, in advance, with the client organisation?

COMMENT BY ASSESSOR

9.1.9 Conducting on-site audits 9.1.9.1 General Does the CB have a process for conducting on-site audits? Does the process include opening meeting at the start of the audit and closing meeting at the conclusion of the audit? 9.1.9.2 Conducting the opening meeting Does the audit team have a formal opening meeting with the client’s management and those responsible for the functions or processes to be audited? Are the opening meeting conducted by the lead auditor? Are audit activities explained including the following: a) introduction of the participants, including an outline of their roles b) confirmation of the scope of certification c) confirmation of the audit plan (including type and scope of audit, objectives and criteria), any changes, and other relevant arrangements with the client, such as the date and time for the closing meeting, interim meetings between the audit team and client’s management d) confirmation of formal communication channels between the audit team and the client e) confirmation that the resources and facilities needed by audit team are available f) confirmation of matters relating to confidentiality g) confirmation of relevant work safety, emergency and security procedures for the audit team h) confirmation of the availability, roles and identities of any guides and observers i) the method of reporting, including any grading of audit findings j) information about the conditions under which the audit may be prematurely terminated k) confirmation that the audit team leader and audit team representing the CB is 2012-01-19

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l) m) n) o) p)

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responsible for the audit and shall be in control of executing the audit plan including audit activities and audit trails confirmation of the status of findings of the previous review or audit, if applicable methods and procedures to be used to conduct the audit based on sampling confirmation of the language to be used during the audit confirmation that, during the audit, the client will be kept informed of audit progress and any concerns opportunity for the client to ask questions

9.1.9.3 Communication during the audit 9.1.9.3.1 During the audit, does the audit team periodically assess audit progress and exchange information and does the team leader re-assign work as needed between the audit team members and periodically communicate the progress of the audit and any concerns to the client? 9.1.9.3.2 Does the audit team leader report to the client and where possible to the CB presence of an immediate and significant risk (e.g. safety) see 9.1.9.3.2? Is the outcome of the action taken reported to the CB? 9.1.9.3.3 Does the team leader review with the client any need for changes to the audit scope which becomes apparent as on-site auditing activities progress and report this to the CB? 9.1.9.4 Observers and guides 9.1.9.4.1 Observers Prior to the conduct of the audit, does the client agree to the presence and justification of observers during an audit activity? Does the team leader ensure that observers do not influence or interfere in the audit process or outcome of the audit? 9.1.9.4.2 Guides Does each auditor accompanied by a guide, unless otherwise agreed to by the audit team leader and the client? Does the audit team ensure that guides do not influence or interfere in the audit process or outcome of the audit? SEE NOTE

9.1.9.5 Collecting and verifying information 9.1.9.5.1 Is information relevant to the audit objective, scope and criteria collected by appropriate sampling and verified to become audit evidence? 9.1.9.5.2 Are methods to collect information included? a) Interviews 2012-01-19

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b) Observation of processes and activities c) Review of documentation and records 9.1.9.6 Identifying and recording audit findings 9.1.9.6.1 Are audit findings summarising conformity and detailing non-conformity audits and its supporting evidence recorded and reported? 9.1.9.6.2 Where opportunities for improvement are not prohibited by the requirements of a management system scheme, are they identified and recorded? 9.1.9.6.3 Is a finding of non-conformity recorded against a specific requirement of the audit criteria and does it contain a clear statement of the nonconformity and identify in detail the objective evidence on which the nonconformity is based? Are non-conformities discussed with the client to ensure that the evidence is accurate and that the non-conformities are understood? 9.1.9.6.4 Does the audit team leader attempt to resolve any diverging opinions between the audit team and the client concerning audit evidence on findings, and are unresolved points recorded?

9.1.9.7 Preparing audit conclusions Prior to the closing meeting, does the audit team a) review the audit findings, and any other appropriate information collected during the audit, against the audit objectives b) agree upon the audit conclusions, taking into account the uncertainty inherent in the audit process c) identify any necessary follow-up actions d) confirm the appropriateness of the audit programme or identify any modification required (e.g. scope, audit time or dates, surveillance frequency, competence) 9.1.9.8 Conduct the closing meeting 9.1.9.8.1

Does the team hold a formal closing meeting with management and are nonconformances presented in such a manner that they are understood, and are timeframes for responding agreed? Is attendance recorded?

9.1.9.8.2 Does the closing meeting include the following: a) advising the client that the audit evidence collected was based on 2012-01-19

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b) c)

d)

e) f)

CB’s References

COMMENT BY ASSESSOR

sample of the information; thereby introducing an element of uncertainty the method and timeframe of reporting, including any grading of audit findings the certification body’s process for handling nonconformities including any consequences relating to the status of the client’s certification the timeframe for the client to present a plan for correction and corrective action for any nonconformities identified during the audit the CB’s post audit activities information about the complaint handling and appeal processes

9.1.9.8.3 Is the client given opportunity for questions? Are diverging opinions regarding the audit findings or conclusions discussed, resolved where possible? Are unresolved diverging opinions recorded and referred to the CB? 9.1.10 Audit report 9.1.10.1 Does the CB provide a written report for each audit and is ownership of the report maintained by the CB? If the audit team identifies opportunities for improvement , do they recommend specific solutions? 9.1.10.2 Does the team leader ensure that the report is prepared and takes responsibility of the contents of the report? Does the report provide accurate, concise and clear record of the audit and does it include the following: (a) identification of the certification body (b) the name and address of the client’s management representative (c) the type of audit (e.g. initial, surveillance or recertification) (d) the audit criteria (e) the audit objectives (f) the audit scope, particularly identification of the organisational or functional units or processes audited and the time of the audit (g) identification of the audit team leader, audit team members and any accompanying persons (h) the dates and places where the audit activities (on site or offsite) were 2012-01-19

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COMMENT BY ASSESSOR

and the

9.1.11 Cause analysis of nonconformities Does the CB require the client to analyse the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time? 9.1.12 Effectiveness of corrections and corrective actions Does the CB review the corrections, identified causes and corrective actions submitted by the customer to determine if these are acceptable? Does the CB verify the effectiveness of any correction and corrective actions taken? Is the evidence obtained to support the resolution of nonconformities recorded? Does the client gets informed of the result of the review and verification? SEE NOTE 9.1.13 Certification decision Is the client informed if an additional full audit, an additional limited audit, or documented evidence (to be confirmed during future surveillance audits) will be needed to verify effective correction and corrective actions 9.1.14 Does the CB ensure that the persons or committees that make the certification or recertification decisions are different from those who carried out the audits? 9.1.15 Actions prior to making a decision Does the CB confirm, prior to making a decision, that: a) the information provided by the audit team is sufficient? b) it has reviewed, accepted and verified the effectiveness of correction and corrective actions, for all nonconformities that represent: 1) failure to fulfil one or more requirements of the management system standard? or 2) a situation that raises significant doubt about the ability of the customer’s management system to achieve its intended outputs? c) it has reviewed and accepted the client’s planned correction and corrective action for any other non-conformities?

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9.2 Initial audit and certification. 9.2.1 Application Does the CB require an authorized representative of the applicant organization to provide the necessary information to enable it to establish: a) the desired scope of the certification? b) the general features of the applicant organization, including its name and the address(es) of its physical location(s), significant aspects of its process and operations, and any relevant legal obligations? c) general information, relevant for the field of certification applied for, concerning the applicant organization, such as its activities, human and technical resources, functions and relationship in a larger corporation, if any? d) information concerning all outsourced processes used by the organization that will affect conformity to requirements? e) the standards or other requirements for which the applicant organization is seeking certification? f) information concerning the use of consultancy relating to the management system?

9.2.2

Application review.

9.2.2.1 Before proceeding with the audit, does the CB conduct a review of the application and supplementary information for certification to ensure that: a) the information about the applicant and its management system is sufficient for the conduct of the audit? b) the requirements for certification are clearly defined and documented, and have been provided to the applicant organization? c) any known difference in understanding between the CB and the applicant organization is resolved? d) the CB has the competence and ability to perform the certification activity? e) the scope of certification sought, the location(s) of the applicants organisation’s operations, time required to complete audits and any other points influencing the certification activity are taken into account (language, safety conditions, threats to impartiality, etc.)? f) records of the justification for the decision to undertake the audit shall be maintained? 9.2.2.2 Following the review of the application, does the CB accept or decline an application or certification? When declined, are reasons for declining documented and made clear to the client? 2012-01-19

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SEE NOTE 9.2.2.3 Based on this review, does the CB determine the competences it needs to include in its audit team (see 7.2 7) and for the certification decision (see 7.2.9)? 9.2.2.4 Is the audit team appointed and do they have the totality of the competences identified by the CB as set out in 9.2.2.3 for the certification of the applicant organization? Is selection of the team performed with reference to the designations of competence of auditors and technical experts made under 7.2.5? 9.2.2.5 Is the individual(s) who will be conducting the certification decision appointed to ensure appropriate competence is available (see 7.2.9 and 9.2.2.3)?

9.2.3

Initial certification audit

Is the initial certification audit of a management system conducted in two stages - Stage 1 and Stage 2?

9.2.3.1 Stage 1 audits 9.2.3.1.1 a)

b)

c)

d)

e)

f)

Is the Stage 1 audit performed: to audit the client’s management system documentation; to evaluate the client’s location and sitespecific conditions and to undertake discussions with the client’s personnel to determine the preparedness for the Stage 2 audit; to review the client’s status and understanding regarding requirements of the standard, in particular with respect to the identification of key performance or significant aspects, processes, objectives and operation of the management system? to collect necessary information regarding the scope of the management system, processes and location(s) of the client, and related statutory and regulatory aspects and compliance (e.g. quality, environmental, legal aspects of the client’s operation, associated risks, etc.)? to review the allocation of resources for Stage 2 audit and agree with the client on the details of the Stage 2 audit? to provide a focus for planning the Stage 2 audit by gaining a sufficient understanding of the client’s management system and site operations in the context of possible significant

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aspects? to evaluate if the internal audits and management review are being planned and performed, and that the level of implementation of the management system substantiates that the client is ready for the Stage 2 audit? For most management systems, it is recommended that at least part of the Stage 1 audit be carried out at the client’s premises in order to achieve the objectives stated above. g)

9.2.3.1.2

Are Stage 1 audit findings documented and communicated to the client organization including identification of any areas of concern that could be classified as non-conformity during the Stage 2 audit?

9.2.3.1.3

In determining the interval between Stage 1 and Stage 2, is consideration given to the needs of the client to resolve areas of concern identified during the Stage 1 audit? The CB may also need to revise its arrangements for Stage 2

9.2.3.2 Stage 2 audit 9.2.3.2.1

a)

b)

c) d) e) f) g)

The purpose of the Stage 2 audit is to evaluate the implementation, including effectiveness, of the customer’s management system. Is the Stage 2 audit taking place at the site(s) of the client? Does it include at least the following: information and evidence about conformity to all requirements of the applicable management system standard or other normative document? performance monitoring, measuring, reporting and reviewing against key performance objectives and targets ? the client’s management system and performance as regards legal compliance? operational control of the client’s processes? internal auditing and management review? management responsibility for the client organization’s policies? links between the normative requirements, policy, performance objectives and targets, any applicable legal requirements, responsibilities, competence of personnel, operations, procedures, performance data, and internal audit findings and conclusions?

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Initial certification audit conclusions

Does the audit team analyse all information and audit evidence gathered during the Stage 1 and Stage 2 audits to review the audit findings and agree on the audit conclusions?

9.2.5 Information for granting initial certification 9.2.5.1 a) b)

c) d)

Does the information provided by the audit team to the CB for the certification decision include, as a minimum: the audit reports? comments on the non-conformities and, where applicable, the correction and corrective actions taken by the client? confirmation of the information provided to the certification body used in the application review (see 9 2.2)? and a recommendation whether or not to grant certification, together with any conditions or observations

9.2.5.2 Does the CB make the certification decision on the basis of an evaluation of the audit findings and conclusions and any other relevant information (e.g. public information, comments on the audit report from the customer)?

9.3 Surveillance activities 9.3.1 General 9.3.1.1

Did the CB developed its surveillance activities so that representative areas and functions covered by the scope of the management system are monitored on a regular basis, and take into account changes to its certified client and its management system?

9.3.1.2

Do surveillance activities include on-site audits assessing the certified client’s management system’s fulfilment of specified requirements with respect to the standard to which the certification is granted? Other surveillance activities may include: enquiries from the CB to the certified client on aspects of certification; reviewing any client’s statements with respect to its operations (e.g. promotional material, website); requests to the client to provide documents and records (on paper or electronic media); and other means of monitoring the certified client’s performance?

a) b) c)

d)

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Surveillance audit

9.3.2.1 Are on-site audits planned together with the other surveillance activities, so that the CB can maintain confidence that the certified management system continues to fulfil requirements in between re-certification audits? Does the surveillance audit programme include, at least: a) internal audits and management review? b) a review of action taken on non-conformities identified during the previous audit? c) treatment of complaints? d) effectiveness of the management system with regard to achieving the certified client’s objectives? e) progress of planned activities aimed at continual improvement? f) continuing operational control? g) review of any changes? and h) use of marks and/or any other reference to certification? 9.3.2.2

9.3.3

Are surveillance audits conducted at least once a year? Is the date of the 1st surveillance audit following initial certification not more than 12 months from the last day of the Stage 2 audit?

Maintaining certification

Does the CB maintain certification based on demonstration that the client continues to satisfy the requirements of the management system standard? Does the CB maintain an organization’s certification based on a positive recommendation by the audit team leader without further independent review, provided that: a) for any non-conformity or other situation that may lead to suspension or withdrawal of certification, the CB needs to initiate a review by appropriately competent personnel different from those who carried out the audit, to determine whether certification can be maintained (see 7.2.9), and b) competent personnel of the CB monitor its surveillance activities, including monitoring the reporting by its auditors, to confirm that the certification activity is operating effectively?

9.4 9.4.1 9.4.1.1

Re-certification Re-certification cycle Is a re-certification audit planned and conducted to evaluate the continued fulfilment of all of the requirements of the relevant management system standard or other normative document?

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9.4.1.2

Does the re-certification audit consider the performance of the management system over the period of certification, and include the review of previous surveillance audit reports?

9.4.1.3

In situations where there have been significant changes (e.g. changes to legislation, management, processes etc.) do the re-certification audit activities include a Stage 1 audit?

9.4.1.4

In the case of multiple sites or certification multiple management system standards being provided by the CB, does the planning for the audit ensure adequate onsite audit coverage to provide confidence in the certification?

9.4.2

Re-certification audit

COMMENT BY ASSESSOR

9.4.2.1

Does the re-certification audit include an on-site audit that addresses the following: a) the effectiveness of the management system? b) demonstrated commitment to maintain the effectiveness and improvement? c) whether the operation of the certified management system contributes to the achievement of the organization’s policy and objectives?

9.4.2.2 When, during a re-certification audit, instances of non-conformity or lack of evidence of conformity are identified, does the CB define time limits for correction and corrective actions to be implemented prior to the expiry of certification?

9.4.3 Information for granting recertification Does the CB make decisions on renewing certification based on: • the results of re-certification audit? • the results of the review of the system over the period of certification? and • the complaints received from users of certification?

9.5 Special audits 9.5.1 Extensions to scope Does the CB, in response to an application for extension to the scope of a certification already granted, undertake a review of the application and determine any audit activities necessary to decide whether or not the extension may be granted? (This may be conducted in conjunction with a surveillance audit)

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Short-notice audits

If it is necessary for the CB to conduct audits of certified clients at short notice to investigate complaints (see 9.8), or in response to changes (see 8.6.3), or as follow up on suspended customers (see 9.6): a) does the CB describe and make known in advance to the certified clients (e.g. in documents as described in 8.6 1) the conditions under which these short notice visits are to be conducted? and b) does the CB exercise additional care in the assignment of the audit team because of the lack of opportunity for the client to object to audit team members?

9.6

Suspending, withdrawing or reducing scope of certification

9.6.1

Does the CB have a policy and documented procedure(s) for suspension, withdrawal or reduction of the scope of certification, and does it specify the subsequent actions by the CB?

9.6.2

Does the CB suspend certification in cases when, for example: the customer’s certified management system has persistently or seriously failed to meet certification requirements, including requirements for the effectiveness of the management system? the certified client does not allow surveillance or re-certification audits to be conducted at the required frequencies? or the certified client has voluntarily requested a suspension

•

•

• 9.6.3

Under suspension the customer’s management system certification is temporarily invalid. • Does the CB have enforceable arrangements with its clients to ensure that in case of suspension the client refrains from further promotion of its certification? • Does the CB make the suspended status of the certification publicly available (see 8.1.3) and take any other measures it deems appropriate?

9.6.4

Does failure to resolve the issues that have resulted in the suspension in a time established by CB result in withdrawal or reduction of the scope of certification? See Note

9.6.5

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the scope of certification? Are such reductions in line with the requirements of the standard used for certification? 9.6.6

Does the CB have enforceable arrangements with the certified customer concerning conditions of withdrawal (see 8.4.3 d) ensuring upon notice of withdrawal of certification that the customer discontinues its use of all advertising matter that contains any reference to a certified status?

9.6.7

Upon request by any party, does the CB correctly state the status of certification of a client’s management system as being suspended, withdrawn or reduced?

9.7 Appeals 9.7.1

Does the CB have a documented process to receive, evaluate and make decisions on appeals?

9.7.2

Is a description of the appeals handling process publicly available?

9.7.3

Is the CB responsible for all decisions at all levels of the appeals handling process? Does the CB ensure that the persons engaged in appeals handling process are different from those who carried out the audits and made the certification decisions?

9.7.4

Do submission, investigation and decision on appeals result in any discriminatory actions against the appellant?

9.7.5

Does the appeal handling process include at least the following elements and methods: a) an outline of the process for receiving, validating, investigating the appeal, and for deciding what actions are to be taken in response to it, taking into account the results of previous similar appeals; b) tracking and recording appeals, including actions undertaken to resolve them; c) ensuring that any appropriate correction and corrective action is taken

9.7.6

Does the CB acknowledge receipt of the appeal and provide the appellant with progress reports and the outcome?

9.7.7

Are the decision to be communicated to the appellant made by, or reviewed and approved by, individual(s) not previously involved in the subject of the appeal?

9.7.8

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9.5 Complaints 9.8.1

Is a description of the complaints handling process publicly accessible?

9.8.2

Upon receipt of a complaint, does the CB confirm whether the complaint relates to certification activities that it is responsible for and, if so, deals with it? If the complaint relates to a certified client does the examination of the complaint consider the effectiveness of the certified management system?

9.8.3

Is a complaint about a certified client also referred by the CB to the certified client in question at an appropriate time?

9.8.4

Does the CB have a documented process to receive, evaluate and make decisions on complaints? Is this process subject to requirements for confidentiality, as it relates to the complainant and to the subject of the complaint?

9.8.5

Does the complaints handling process include at least the following elements and methods: a) an outline of the process for receiving, validating, investigating the complaint, and for deciding what actions are to be taken in response to it? b) tracking and recording complaints, including actions undertaken to resolve them;? c) ensuring that any appropriate correction and corrective actions are taken? See Note 9.8.6 Is the CB receiving the complaint responsible for gathering and verifying all necessary information to validate the complaint? 9.8.7

Whenever possible, does the CB acknowledge receipt of the complaint, and provide the complainant with progress reports and the outcome?

9.8.8

Is the decision to be communicated to the complainant made by, or reviewed and approved by, individual(s) not previously involved in the subject of the complaint?

9.8.9

Whenever possible, does the CB give formal notice of the end of the complaint handling process to the complainant?

9.8.10 Does the CB determine together with the client and the complainant, whether and, if so to what extent, the subject of the complaint and its resolution shall be made public? 2012-01-19

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CB’s References

COMMENT BY ASSESSOR

Records of applicants and clients Does the CB maintain records on the audit and other certification activity for all clients, including all organizations that submitted applications, and all organizations audited, certified, or with certification withdrawn?

9.9.2

Do the records on certified clients include the following: a) application information and initial, surveillance and re-certification audit reports? b) certification agreement? c) justification of the methodology used for sampling? d) justification for auditor time determination (see 9.1.4)? e) verification of correction and corrective actions? f) records of complaints and appeals, and any subsequent correction or corrective actions? g) committee deliberations and decisions, if applicable? h) documentation of the certification decisions? i) certification documents including the scope of certification with respect to product, process or services as applicable? and j) related records necessary to establish the credibility of the certification, such as evidence of the competence of auditor and technical expert? See Note. 9.9.3 Does the CB keep the records on applicants and customers secure to ensure that the information is kept confidential? Are records transported, transmitted or transferred, in a way that ensures that confidentiality is maintained? 9.9.4

Does the CB have a documented policy and documented procedures on retention of records? Are records retained for the duration of the current cycle plus one (1) full certification cycle? See Note

10

Management system requirements for CBs 10.1 Options In addition to meeting the requirements of Clauses 5 to 9, did the CB implement a management system in accordance with either a) management system requirements in accordance with ISO 9001 (Option 1)? or b) general management system requirements (Option 2)?

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10.2

Option 1: Management system requirements in accordance with ISO 9001 10.2.1 General Is the ISO 9001 system capable of supporting and demonstrating the consistent achievement of the requirements of this International Standard, amplified by 10.2.2 to 10.2 4?

10.2.2 Scope Does the scope of the management system include the design and development requirements for its certification services?

10.2.3 Customer focus Does the CB consider the credibility of certification and address the needs of all parties (as set out in 4.1.2) that rely upon its audit and certification services, not just its clients?

10.2.4 Management review Does the CB include as input for management review, information on relevant appeals and complaints from users of certification activities?

10.3

Option 2: General management system requirements 10.3.1 General Does the CB establish, document, implement and maintain a management system that is capable of supporting and demonstrating the consistent achievement of the requirements of this International Standard? Does the CB’s top management establish and document policies and objectives for its activities? Does top management provide evidence of its commitment to the development and implementation of the management system in accordance with the requirements of this International Standard? Does top management ensure that the policies are understood, implemented and maintained at all levels of the certification body’s organisation? Did the CB’s top management appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes: a) ensuring that processes and procedures needed for the management system are established, implemented and maintained? and b) reporting to top management on the performance of the management system and any need for improvement?

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10.3.2 Management system manual Are all applicable requirements of this International Standard addressed either in a manual or in associated documents? Does the CB ensure that the manual and relevant associated documents are accessible to its personnel?

10.3.3 Control of documents Did the CB establish procedures to control the documents (internal and external) that relate to the fulfilment of this International Standard? Does the procedures define the controls needed: a) to approve documents for adequacy prior to issue? b) to review and update as necessary and reapprove documents? c) to ensure that changes and the current revision status of documents are identified? d) to ensure that relevant versions of applicable documents are available at points of use? e) to ensure that documents remain legible and readily identifiable? f) to ensure that documents of external origin are identified and their distribution controlled? and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? See Note.

10.3.4 Control of Records Does the CB establish procedures to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of its records related to the fulfilment of this International Standard? Does the CB establish procedures for retaining records for a period consistent with its contractual and legal obligations? Is access to these records consistent with the confidentiality arrangements? See Note

10.3.5 Management review 10.3.5.1 General Did the CB’s top management establish procedures to review its management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness including the stated policies and objectives related to the fulfilment of this International Standard? Are these reviews conducted at least once a year?

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10.3.5.2

Review inputs Does the input to management review include information related to: a) results of internal and external audits? b) feedback from clients and interested parties related to the fulfilment of this International Standard? c) feedback from the committee for safeguarding impartiality? d) status of preventive and corrective actions? e) follow-up actions from previous management reviews? f) fulfilment of objectives? g) changes that could affect the management system? and h) appeals and complaints?

10.3.5.3

Review outputs Do the outputs from the management review include decisions and actions related to: a) improvement of the effectiveness of the management system and its processes? b) improvement of the certification services related to the fulfilment of this International Standard? and c) resource needs?

10.3.6 Internal Audits 10.3.6.1

Does the CB establish procedures for internal audits to verify that it fulfils the requirements of this International Standard and that the management system is effectively implemented and maintained? See Note

10.3.6.2

Is an audit programme planned, taking into consideration the importance of the processes and areas to be audited as well as the results of previous audits?

10.3.6.3

Are internal audits performed at least once every 12 months?

10.3.6.4 Does the CB ensure that: a) internal audits are conducted by qualified personnel knowledgeable in certification, auditing and the requirements of this International Standard? b) auditors shall not audit their own work? c) personnel responsible for the area audited are informed of the outcome of the audit? d) any actions resulting from internal audits are taken in a timely and appropriate manner? and e) any opportunities for improvement are identified?

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10.3.7 Corrective Actions Does the CB establish procedures for identification and management of non-conformities in its operations? Does the CB also, where necessary, take actions to eliminate the causes of non-conformities in order to prevent recurrence? Are corrective actions appropriate to the impact of the problems encountered? Do the procedures define requirements for: a) identifying non-conformities (e g. from complaints and internal audits)? b) determining the causes of nonconformity? c) correcting non-conformities? d) evaluating the need for actions to ensure that non-conformities do not recur? e) determining and implementing in a timely manner, the actions needed? f) recording the results of actions taken? and g) reviewing the effectiveness of corrective actions?

10.3.8 Preventive Actions Does the CB establish procedures for taking preventive actions to eliminate the causes of potential non-conformities? Are preventive actions taken appropriate to the probable impact of the potential problems? Do the procedures for preventive actions define requirements for: a) identifying potential non-conformities and their causes? b) evaluating the need for action to prevent the occurrence of non-conformities? c) determining and implementing the action needed? d) recording the results of actions taken? and e) reviewing the effectiveness of the preventive actions taken.? See Note.

Signed : Lead Assessor / Assessor

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Date

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